Opportunity Information: Apply for RFA HL 19 028

The NIH funding opportunity RFA-HL-19-028, titled "HEAL Initiative: Sleep and Circadian-Dependent Mechanisms Contributing to Opiate Use Disorder (OUD) and Response to Medication Assisted Treatment (MAT)" supports R01 research projects that focus on how sleep and circadian biology shape opioid addiction risk, withdrawal biology, and responses to medication-assisted treatment. The central goal is to push basic and translational understanding of the underlying mechanisms linking sleep and circadian systems to OUD, rather than simply describing associations. In practical terms, NIH is looking for studies that can clarify how disruptions in sleep or circadian timing might contribute to developing OUD, how opioid exposure and withdrawal may in turn disrupt sleep and circadian function, and how those bidirectional effects could influence treatment response and recovery outcomes when medications like MAT are used.

A major emphasis of the announcement is directionality and mechanism. Applicants are expected to move beyond correlation and address questions such as whether sleep or circadian disruption increases vulnerability to OUD, whether OUD-related neuroadaptations produce sleep and circadian pathology that worsens withdrawal or relapse risk, and which neurobiological pathways are responsible for these interactions. The FOA highlights the need to apply modern advances in sleep and circadian neurobiology to opioid-use-related questions, with an eye toward identifying actionable targets that could improve therapy and outcomes. While the topic is clinically relevant, the mechanism-focused framing signals strong interest in foundational biology that can explain why sleep and circadian factors matter for opioid use, withdrawal severity, and treatment effectiveness.

The FOA strongly encourages multidisciplinary, team-based applications. Competitive projects are expected to bring together investigators with complementary expertise, specifically combining sleep and circadian neurobiology with the neurobiology of OUD and the pharmacology of medication-assisted treatment. This team science orientation reflects the complexity of the problem: integrating neural circuit mechanisms, molecular and cellular pathways, pharmacologic effects of MAT, and measurable sleep/circadian phenotypes to build coherent mechanistic models that can ultimately inform better interventions.

The scope is intentionally narrow regarding substances studied. The FOA is only responsive to research focused on OUD-relevant mechanisms and pathobiology. Studies centered on other drugs of abuse are explicitly non-responsive, meaning an application that primarily examines non-opioid substances (even if sleep and circadian issues are involved) would not fit this announcement. The funding mechanism is an R01, and the opportunity is designated "Clinical Trial Not Allowed," which generally means applicants should not propose prospective studies in which human participants are assigned to interventions to evaluate health-related outcomes. Applicants can still often include human-oriented mechanistic work if it does not meet the NIH definition of a clinical trial, but the intent here is to keep the portfolio focused on mechanistic research rather than interventional trials.

From an administrative standpoint, this is a discretionary NIH grant opportunity under health-related CFDA program areas (93.233, 93.279, 93.837, 93.838, 93.839). The opportunity lists an award ceiling of $350,000 (as provided in the source data) and had an original closing date of February 27, 2019, with a creation date of December 10, 2018. While the closing date indicates this specific FOA is historical, the summary still captures what NIH was soliciting under this announcement and can be useful as a guide to the kind of research themes NIH has prioritized under the HEAL Initiative.

Eligibility is broad across U.S.-based organizations and includes many government and non-government applicant types. Eligible applicants include state, county, city/township, and special district governments; independent school districts; public and state-controlled institutions of higher education; private institutions of higher education; federally recognized Native American tribal governments; tribal organizations other than federally recognized governments; public housing authorities/Indian housing authorities; nonprofits with or without 501(c)(3) status (other than institutions of higher education); for-profit organizations other than small businesses; small businesses; and other eligible entities. The FOA also explicitly calls out additional eligible applicant categories such as Alaska Native and Native Hawaiian Serving Institutions, AANAPISISs, Hispanic-serving Institutions, Historically Black Colleges and Universities, Tribally Controlled Colleges and Universities, faith-based or community-based organizations, regional organizations, U.S. territories or possessions, eligible federal government agencies, and Indian/Native American tribal governments other than federally recognized.

At the same time, the FOA clearly restricts foreign involvement. Non-domestic (non-U.S.) entities and non-domestic (non-U.S.) institutions are not eligible to apply. Non-domestic components of U.S. organizations are also not eligible, and foreign components (as defined by NIH Grants Policy) are not allowed. In other words, the work and organizational footprint supported by this FOA must remain domestic, with no foreign components built into the proposed project structure.

Overall, this opportunity targets mechanistic, opioid-specific research at the intersection of sleep/circadian biology and OUD, including withdrawal and MAT response, with a clear preference for integrative, cross-disciplinary teams and a firm exclusion of clinical trials and non-opioid substance-focused studies. The intended payoff is a sharper, mechanistically grounded understanding of how sleep and circadian systems influence opioid addiction trajectories and treatment response, creating a foundation for improved therapeutic strategies and better recovery outcomes in the future.

  • The National Institutes of Health in the education, health sector is offering a public funding opportunity titled "HEAL Initiative: Sleep and Circadian-Dependent Mechanisms Contributing to Opiate Use Disorder (OUD) and Response to Medication Assisted Treatment (MAT) (R01 - Clinical Trial Not Allowed)" and is now available to receive applicants.
  • Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.233, 93.279, 93.837, 93.838, 93.839.
  • This funding opportunity was created on 2018-12-10.
  • Applicants must submit their applications by 2019-02-27. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
  • Each selected applicant is eligible to receive up to $350,000.00 in funding.
  • Eligible applicants include: State governments, County governments, City or township governments, Special district governments, Independent school districts, Public and State controlled institutions of higher education, Native American tribal governments (Federally recognized), Public housing authorities/Indian housing authorities, Native American tribal organizations (other than Federally recognized tribal governments), Nonprofits having a 501 (c) (3) status with the IRS, other than institutions of higher education, Nonprofits that do not have a 501 (c) (3) status with the IRS, other than institutions of higher education, Private institutions of higher education, For-profit organizations other than small businesses, Small businesses, Others.
Apply for RFA HL 19 028

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Frequently Asked Questions (FAQs)

What is the funding opportunity RFA-HL-19-028 about?

RFA-HL-19-028 is an NIH funding opportunity titled "HEAL Initiative: Sleep and Circadian-Dependent Mechanisms Contributing to Opiate Use Disorder (OUD) and Response to Medication Assisted Treatment (MAT)." It supports R01 research projects that investigate how sleep and circadian biology influence opioid addiction risk, withdrawal biology, and responses to medication-assisted treatment, with an emphasis on explaining mechanisms rather than reporting simple associations.

What is the main goal of this FOA?

The central goal is to advance basic and translational understanding of the underlying mechanisms linking sleep and circadian systems to OUD and to MAT response. The focus is on directionality and cause-and-effect biology (how sleep/circadian disruption may contribute to OUD, how opioid exposure/withdrawal may disrupt sleep/circadian function, and how these bidirectional effects may influence treatment and recovery outcomes).

What kinds of research questions is NIH encouraging under this announcement?

The FOA encourages studies that clarify:

  • Whether disruptions in sleep or circadian timing increase vulnerability to developing OUD.
  • How opioid exposure and withdrawal may produce sleep and circadian disruptions.
  • Whether OUD-related neuroadaptations create sleep/circadian pathology that worsens withdrawal, relapse risk, or recovery trajectories.
  • Which neurobiological pathways (molecular, cellular, and circuit-level) mediate these relationships.
  • How sleep/circadian factors may shape response to medication-assisted treatment (MAT).

Is this FOA interested in descriptive or correlational studies?

Not primarily. The FOA emphasizes mechanism and directionality. Applicants are expected to move beyond describing correlations and instead test hypotheses about causation and underlying biological pathways that link sleep/circadian systems with OUD and MAT response.

How does the HEAL Initiative fit into this opportunity?

This FOA is positioned under the NIH HEAL Initiative and targets opioid-specific research that can strengthen the biological foundation for improved therapeutic strategies and better recovery outcomes. The emphasis is on actionable mechanistic understanding rather than purely observational links.

What funding mechanism does this opportunity use?

The funding mechanism is an NIH R01 research project grant.

Are clinical trials allowed under this FOA?

No. The opportunity is designated "Clinical Trial Not Allowed." That generally means applicants should not propose prospective studies in which human participants are assigned to interventions to evaluate health-related outcomes. The intent is to keep the supported work focused on mechanistic research rather than interventional clinical trials.

Can human-focused research still be included if clinical trials are not allowed?

The FOA indicates that clinical trials are not allowed, but it also notes that human-oriented mechanistic work may be possible if it does not meet the NIH definition of a clinical trial. The overall framing remains focused on mechanistic understanding rather than intervention testing.

What substances are in-scope for this FOA?

The scope is intentionally narrow: studies must be focused on opioid use disorder (OUD)-relevant mechanisms and pathobiology.

Are studies about other drugs of abuse allowed?

No. Studies centered on other drugs of abuse are explicitly described as non-responsive. Applications that primarily examine non-opioid substances, even if sleep and circadian issues are included, do not fit this announcement.

What does NIH mean by focusing on mechanisms in this FOA?

Mechanism-focused projects are expected to explain how and why sleep/circadian disruption and OUD influence one another. This includes identifying neurobiological pathways and integrating modern advances in sleep and circadian neurobiology with opioid-use-related neurobiology and MAT pharmacology, rather than simply documenting that sleep problems and OUD co-occur.

Is multidisciplinary or team-based science encouraged?

Yes. The FOA strongly encourages multidisciplinary, team-based applications. Competitive projects are expected to integrate complementary expertise, specifically combining sleep and circadian neurobiology with OUD neurobiology and the pharmacology of medication-assisted treatment.

What kinds of expertise does NIH expect teams to include?

The FOA specifically highlights the value of combining:

  • Sleep and circadian neurobiology expertise
  • Neurobiology of opioid use disorder
  • Medication-assisted treatment (MAT) pharmacology

This reflects the need to connect neural circuits, molecular/cellular pathways, pharmacologic effects of MAT, and measurable sleep/circadian phenotypes into coherent mechanistic models.

What is the stated award ceiling for this opportunity?

The opportunity lists an award ceiling of $350,000 (as provided in the source data).

What are the CFDA program areas listed for this opportunity?

The FOA is associated with CFDA program areas 93.233, 93.279, 93.837, 93.838, and 93.839.

When was this FOA created and when did it close?

The creation date listed is December 10, 2018, and the original closing date listed is February 27, 2019. Based on those dates, this specific FOA is historical, but it still provides a clear picture of the research themes NIH sought under this announcement.

Who is eligible to apply?

Eligibility is broad across U.S.-based organizations and includes many government and non-government applicant types. Examples include:

  • State, county, city/township, and special district governments
  • Independent school districts
  • Public and state-controlled institutions of higher education
  • Private institutions of higher education
  • Federally recognized Native American tribal governments
  • Tribal organizations other than federally recognized governments
  • Public housing authorities/Indian housing authorities
  • Nonprofits with or without 501(c)(3) status (other than institutions of higher education)
  • For-profit organizations other than small businesses
  • Small businesses
  • Other eligible entities

Are specific institution types explicitly called out as eligible?

Yes. The FOA explicitly calls out additional eligible categories, including Alaska Native and Native Hawaiian Serving Institutions, AANAPISISs, Hispanic-serving Institutions, Historically Black Colleges and Universities, Tribally Controlled Colleges and Universities, faith-based or community-based organizations, regional organizations, U.S. territories or possessions, eligible federal government agencies, and Indian/Native American tribal governments other than federally recognized.

Are foreign (non-U.S.) organizations eligible to apply?

No. Non-domestic (non-U.S.) entities and non-domestic institutions are not eligible to apply.

Are foreign components allowed if the applicant is a U.S. organization?

No. The FOA states that non-domestic components of U.S. organizations are not eligible and that foreign components (as defined by NIH Grants Policy) are not allowed. The supported work and organizational footprint must remain domestic.

What is the intended impact of projects funded under this FOA?

The intended payoff is a sharper, mechanistically grounded understanding of how sleep and circadian systems influence opioid addiction trajectories, withdrawal severity, relapse risk, and treatment response to MAT. This foundation is meant to inform improved therapeutic strategies and better recovery outcomes over time.

What would likely make an application non-responsive to this FOA?

Based on the announcement summary, applications would likely be non-responsive if they:

  • Primarily focus on drugs of abuse other than opioids
  • Propose clinical trials (since "Clinical Trial Not Allowed" is specified)
  • Rely mainly on correlational/descriptive relationships without testing mechanisms or directionality
  • Include foreign components or are submitted by non-U.S. entities

Does the FOA emphasize basic research, translational research, or both?

Both. The FOA aims to push basic and translational understanding of mechanisms linking sleep/circadian biology with OUD and MAT response, emphasizing foundational biology that can explain observed clinical relevance and point toward actionable targets.

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